Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients
Authors: Nicolas M. Van Mieghem, G. Michael Deeb, Lars Søndergaard, Eberhard Grube, Stephan Windecker, Hemal Gada, Mubashir Mumtaz, Peter S. Olsen, John C. Heiser, William Merhi, Neal S. Kleiman, Stanley J. Chetcuti, Thomas G. Gleason, Joon Sup Lee, Wen Cheng, Raj R. Makkar, Juan Crestanello, Barry George, Isaac George, Susheel Kodali, Steven J. Yakubov, Patrick W. Serruys, Rüdiger Lange, Nicolo Piazza, Mathew R. Williams, Jae K. Oh, David H. Adams, Shuzhen Li, Michael J. Reardon, Christopher Gitter, Karen Meyer, Dana Roberts, Richard Bae, Paul Sorajja, Benjamin Sun, Judah Askew, Frazier Eales, Thomas Flavin, Mario Goessl, Vibhu Kshettry, Michael Mooney, Wesley Pedersen, Anil Poulose, Pezhman Roohani, Robert Saeid Farivar, Richard Shronts, Ronald Tarrel, Mark Young, Eddy Butkus, Kristin Pendleton, Robert Fry, Carl Heine, Kristin La Roe, Tin Tran, Laura Weig, Himanshu Agarwal, Thomas Langdon, Ruby Satpathy, John Batter, Karen Bremer, Unajyothi Indukuri, Marijke Baas, Corry Oomes-Sistermans, Manola Smits, Carien Coenen, Inge Driesen, Lia Lauryssen, Margreet Poorter, Jeroen Schaap, Mohamed Bentala, Peter den Heijer, Jan Pieter, Michel Remmers, Marie Story, Paul M.M. van Erven, Henk Verbiest, Jeroen Vos, Michelle Bennett, Wendy Dunaj, Deborah Seaton, Deborah Waller, Bijoy Khandheria, Tanvir Bajwa, Daniel O'Hair, Arshad Ahmed, Suhail Allaqaband, Ayman Gheith, Elizabeth Marriott, Ajaz Qhavi, Varun Kumar Saxena, Akram Shhadeh, Paul Werner, Christine Yeomans, Lynn Bessette, Jessica Byrne, Heather Kieckhefer, Marleny Munoz, Elizabeth Russo, Jason Klein, Michael Morgan, Timothy Byrne, Michael Caskey, Orazio Amabile, Kevin Brady, Steven Chung, Kelly Dacanay, H. Kenith Fang, Douglas Franz, Claire Kelly, Akil Loli, Jeremy Payne, Ashish Pershad, Norman Wang, Jessi Lott, C. Angele Pool-Owens, Charlotte Porter, Jeffrey A. Hennan, H. Edward Garrett, Basil Paulus, John Craig, Lucas Elijovich, Joseph Samaha, Bradley Wolf, Lance Wright, Gilbert Zoghbi, Leslie Willcott, Brad Roberts, Robert Hebeler, Robert Stoler, Dion Graybeal, Paul Grayburn, Carl Henry, Osman Mir, Ravi Vallabhan, Matthew Fanous, Jenifer Kaufman, James Chang, Warren Manning, Marilyn Riley, Kamal Khabbaz, Roger Laham, Jeffrey Popma, David Burke, Louis Caplan, Shing Fung Chui, Kim Guibone, Sandeep Kumar, Vasileios-Arsenios Lioutas, David Liu, Senthil Nathan, Duane Pinto, D. Eric Searls, Susan Fisher, Lindsay Guirgues, Sue Henderson, Laura Ashley Loving, Nicole McWalters, Kelly Patterson, Jesse Burkart, Bryan Carcedo, Russell Stacey, Mark Bladergroen, David Scott Lim, Supakunya Edmonson, Stacey Epps, Marc Robert Katz, Ken Ng, Amandeep Sangha, Jennifer Aucoin, Monique Roberts, Jaime Aubin, Callie Hotard, Michelle Tassin, Peter Fail, Edgar Feinberg, Donald Netherland, Richard Abben, Mohamad Allam, Michael Bates, Richard Dearman, Donald Gervais, Edward Haight, Michael Metes, Jeanette Naquin, Victor Tedesco, Lisa Thibodeaux, Karen Thompson, Sally Aberle, Dana Amaro, William Grey, Geoffrey Rose, Markus Scherer, Michael Rinaldi, Eric Skipper, Charles Bridges, William Downey, Phaniraj Iyengar, Jerry Martin, Liam Ryan, Robert Stiegel, John S. Story, Khaled Alsabaawi, Mitch Gheorghiu, Chetana Singh, Jason Yashar, Robert Siegel, Wen Cheng, Raj Makkar, Karen Altman, Hasan Jilaihawi, Saibal Kar, Stephanie Khouw, Cyrus Mody, Danny Ramzy, Tracey Salseth, Jasminka Stegic, Alfredo Trento, Rosa Lazarte, Jeanie Sohn, Rebecca Hahn, Omar Khalique, Isaac George, Susheel Kodali, Mathew Williams, Marco Gonzalez Castellon, Jose Gutierrez Contreras, Tomoko Kitago, Benjamin Kummer, Tim Lekic, Eliza Miller, Yoshifumi Naka, Tamim Nazif, Abid Qureshi, Sara Rostanski, Craig Smith, Joshua Willey, Shadi Yaghi, Leana Abreu, Emerson Clement, Sajjad Sabir, Janah Aji, Frank Bowen, Georges Kaddissi, Thomas Mirsen, Muhammad Muntazar, Jeffrey Ogbara, Michael Rosenbloom, Wendy Schell, Ryna Then, Heidi Carl, Hong Huang, Ghassan Kreydi, Heather Wolak, Gregory Sandidge, Omar Ali, Zewditu Asfaw, Scott Henry, Ali Kafi, Theodore Schreiber, Lourdes Andaya, Frank Baciewicz, Joseph Bassett, Nishit Choksi, Safwan Kassas, Ahmad Munir, Franziska Kothmeier, Annemarie Stroh, Gertrud Goppel, Ina Hettich, Sabine Bleiziffer, Christian Hengstenberg, Anke Opitz, Hendrik Ruge, Catalin Constantin Badiu, Susanne Brenner, Yacine Ehlmidi, Ulf Herold, Albert Kasel, Robert Josef Kreuzpointner, Rüdiger Lange, Domenico Mazzitelli, Holger Poppert, Christian Seifert, Dóra Vincze, Bernhard Voss, Krista Camuglia, Dahlia Cowhig, Stephanie Newbold, Cynthia Pierce, Samantha Wootton, Sreekanth Vemulapalli, Eric Velazquez, J. Kevin Harrison, G. Chad Hughes, Yasmin Ali, Ali Babi, Adam Banks, Jeffrey Gaca, Donald Glower, Sankalp Gokhale, Sharif Halim, Robert Hendry, Christian Hernandez, Todd Kiefer, Michael Klein, Bradley Kolls, Eric Marrotte, Andres Pineda Maldonado, Andrew Price, Matthew Sherwood, Christa Swisher, David Van Wyck, John Vavalle, Amit Vora, Andrew Wang, Yuriy Zeylikman, Kara Amber, Anne Barnitt, Janet Lamm, Lara Mandelstam, Ryan Schroeder, Roxanne Sumner, Deepu Nair, Ajanta De, Vincent Gaudiani, James Joye, Lidia Brown, Christine Hessler, Chad Rammohan, Conrad Vial, Elizabeth Charles, Angela DeQuesada, Maria Kaner, Sonya Mathewson, Kristy Pitts, Lauren Wheeler, Ashley Wilson, Estella Davidson, Stephen Frohwein, Stamatios Lerakis, John Merlino, Angela Sullivan, Vasilis Babaliaros, Robert Guyton, Vinod Thourani, Aaron Anderson, Samir Belagaje, Karima Benameur, Chandan Devireddy, James Greene, Amy Harrison, Kristen Hudson, Bradley Leshnower, William Lieppe, Steven Macheers, Kreton Mavromatis, Jeffrey Miller, Fadi Nahab, Keith A. Sanders, Eric Sarin, James Stewart, Daniel Winkel, Liesbeth W. Duininck, Titia Gussinklo, Shashikala Jadoenath-Oedai, Arno Ruiter, Nico van den Berg, Liz E.N. van der Velden-Macauley, Maaike van Huis, Silvia G.R. Verelst, Marcel Leonard Geleijnse, Wim B. Vletter, Margaretha Bekker, A. Pieter Kappetein, Nicolas M. Van Mieghem, Joseph A. Bekkers, Karla Biesheuvel, Ozcan Birim, Goris Bol Raap, Joost Daemen, Peter Paul de Jaegere, Rob de Lind van Wijngaarden, Ladbon Khajeh, Charles Kik, Peter J. Koudstaal, Frans B.S. Oei, Maaike Scheele, Pieter van de Woestijne, Robert-Jan van Geuns, Wouter J. van Leeuwen, Amy Henderson, Faye Straight, David Schneider, Marc Tischler, Harold Dauerman, Frank Ittleman, Joseph Schmoker, Abraham Abernethy, Imran Alkhalil, Amir Azarbal, Sreedivya Chava, Christopher Commichau, David Coyle, Jan Denkmann, Christine Destephan, Gregory Ehle, Mohamed El-Haddad, Catherine Falduto, Mark Gorman, Sabeeda Kadavath, Bruce Leavitt, Allison Mack, Gangadhar Malasana, Shahab Moossavi, Newton Phuong, Mehdi Rambod, Naveen Seecheran, Ashwini Sharma, Edward Terrien, Barbara Worgan, Magdalena Zeglin-Sawczuk, Brian Burgess, Susan Killbride, Amy Temple, Joyce Burnside, Christopher Good, Shikhar Agarwal, Alfred Casale, Kimberly Skelding, Russell Carter, Christopher Cummings, Vicente Grana, Carl Haegerl, Kishore Harjai, Neil Holland, Deepak Singh, Russell Stahl, Joseph Stella, Birute Stewart, Doug Long, Kim Wood, Donna Alexander, Sally Barton, Elaine Logtens, Anna-Marie Marsh, John McAdam, Jan Kovac, Giovanni Mariscalco, Tomasz Spyt, Soumitra Garimella, Jacek Szostek, Viktor Zlocha, Lavonda Kirkland, Lori Reid, Susan Reilly, Melody Menderhall, William Martin, Steven Park, Puvi Seshiah, J. Michael Smith, Karen Gersch, Loren Hiratzka, John Kachoris, Eric Okum, Maria Cardozo, Giselle Cyr, W. Lane Duvall, Aidan Flynn, Nancy Krupowies, Matthew Parker, Robert Hagberg, Raymond McKay, Talhat Azemi, Robert Brown, Daniel Fusco, Jonathan Hammond, Catherine Hosley, Francis Kiernan, Ronan Margey, Paul Preissler, Immad Sadiq, Isaac Silverman, Susan Taboada, David Underhill, Jose Escobar, Becky Lopez, Stephanie Mullin, Christine Quesada, Tracy Lawrence, Tasneem Naqvi, Ray V. Matthews, Vaughn Starnes, Leonardo Clavijo, Mark Cunningham, May Kim-Tenser, Nerses Sanossian, David Shavelle, Danielle DelMotte, Samantha Henry, JoAnne Moltrassie, Ashish Solanki, Raymond Cooper, James Lee, Sachin Parikh, Dee Dee Wang, Brian Zweig, William O'Neill, Gaetano Paone, Jamil Borgi, Robert Brewer, Marvin Eng, Adam Greenbaum, Mayra Guerrero, Daniel Miller, Panayiotis Mitsias, Jeffrey Morgan, Hassan Nemeh, Javier Alcaide Muñoz, Maria Medina Fernandez, Fernando Carrasco Chinchilla, Isabel Rodríguez Bailón, José Maria Hernández García, Miguel Such, Juan Alonso-Briales, Carlos De La Cruz Cosme, Antonio Dominguez-Franco, Maria J. Mataró López, Jose Maria Melero, Antonio-Jesus Muñoz-Garcia, Gemma Sanchez Espin, Jose Manuel Fernández Maese, Marta Torres, Esther Villa Suarez, Jesus M. De La Hera, Juan Carlos Llosa Cortina, Cesar Morís de la Tassa, Pablo Avanzas Fernández, Lorena Benavente Fernández, Sergio Calleja, Raquel Del Valle, Carlos Morales Pérez, Jacobo Silva, Eva Bluntschli, Dorothee Keller, Sandra Maritz, Rafael Ruest, Christa Schönenberger, Moreno Trovato, Nicolas Brugger, Volkhard Göber, Reto Kurmann, Sylvia Reineke, Fabian Zürcher, Thierry Carrel, Stephan Windecker, Marcel Arnold, Rupashani Balasubramaniam, Sebastian Bellwald, Morin Beyeler, Anne Broeg, Monika Bühlmann, Lutz Büllesfeld, Lukas Capek, Panagiotis Chaloulos-Lakovidis, Noe Corpataux, Lars Englberger, Steffen Gloekler, Martina Beatrice Goldlin, Christoph Huber, Ahmed Khattab, Rebekka Kurmann, Jonas Lanz, Kai Liesirova, Basel Maamari, Heinrich Mattle, Thomas Meinel, Leonidas Panos, Fabien Praz, Florian Schönhoff, Agnieszka Sleszak, Alessandro Spirito, Stefan Stortecky, Lukas Vaisnora, Rascha Von Martial, Peter Wenaweser, Katarzyna Zuk, Iris Musso, Meredith Allen, Michael Gonzales, Ken Horton, John Doty, Brian Whisenant, William Caine, Stephen Clayson, James Harkness, Robert Hoesch, Mengjing Chloe Huan, Kent Jones, Edward Miner, Bruce Reid, Elizabeth Sunderman, Kathleen Citro, Michele Fisher, Judi Willhide, Mary Corretti, John Conte, Kaushik Mandal, Jon Resar, Matthews Chacko, Rani Hasan, Barbara Heil, Elizabeth Marsh, Joel Price, Chris Sciortino, Ashish Shah, Jennie Tolentino, Anh Bui, Ming Sum Lee, Colin Watanabe, Vicken Aharonian, Naing Moore, Thomas Pfeffer, Zahra Ajani, Prakash Mansukhani, Navdeep Sangha, Kwok Yun, Susanne Hylander, Magnus Bäck, Matthias Corbascio, Carl-Gustaf Hillebrant, Andreas Rück, Rodney De Palma, Kari Feldt, Konstantinos Kostulas, Magnus Settergren, Keita Yamasaki, Michelle Anderson, Charlotte E. 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Bode, Angela Fuchs, Eberhard Grube, Friedrich Mellert, Gabor Petzold, Alex Sedaghat, Jan-Malte Sinning, Mariuca Vasa-Nicotera, Nikos Werner, Helle Bang, Bente Birgitte Brodersen, Pernille Roed Christensen, Elsebet Eriksen, Susanne Groth, Mie Christa Jensen Larsen, Mette Ellegaard Johansen, Line Kristensen, Thomas Nikolaj Lilleør, Lisette Lund Larsen, Anne-Cathrine Preis, Jeanette Rieck-Broberg, Tine Rosenberg, Nikolaj Ihlemann, Jacob Møller, Betina Noerager, Peter Skov Olsen, Lars Søndergaard, Daniël Steinbrüchel, Henrik Andersen, Henrik Arendrup, Gintautas Bieliauskas, Christian Carranza, Ole De Backer, Olaf Franzen, Klaus Hansen, Joan Højgaard, Susanne Holme, Morten Kjøeller, Jens Lund, Mario Perko, Kare Sander, Morten Smerup, Jens Juel Thiis, Hans Gustav Thyregod, Kathryn Monnin, Lori Popelas, Martha Slyman, Kanny Grewal, Todd Matros, David Richards, Daniel Watson, Steven Yakubov, Arash Arshi, Geoffrey Blossom, Anthony Chapekis, Steven Duff, William Hicks, Stephanie Holland, Nathan Howard Kander, Jefferson Lyons, Jennifer Mejilla, Brenda Reese, Carlos Sanchez, Nirav Vora, Sheila Erwin, Jamie Hall, Natalie Hayes, Dana King, Margie Miller, Michael Main, Keith Allen, Adnan Chhatriwalla, Sanjeev Aggarwal, Michael Borkon, Christine Boutwell, David Cohen, J. 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Michael Deeb, Eric Adelman, Mary Jo Boyle, Rachel Geml, P. Michael Grossman, Danielle Guerin, Kelley Hodges, Karen Kim, Deborah Lammers, Margaret McDermott, Daniel Menees, Robert Pace, Himanshu Patel, Richard Prager, Sindhu Ramchandren, Matthew Romano, Angela Stamper, Michael Wang, Darin Zahuranec, Melanie Ziarkiewicz, Cheryl Charlebois, Colleen Chilton, Marino Labinaz, Marc Ruel, Chris Glover, Khanh Lam, Roy Masters, Nikolai Steffenhagen, Melissa Enlow-Germovsek, Kristin Konopka, Rachel McGargle, Melissa Travis, Kathy Anderson, Joao Cavalcante, Fred Crock, Kathy Edelman, William Katz, Thomas Gleason, Joon Sup Lee, Ibrahim Sultan, Amin Nima Aghaebrahim, Alhamza Al-Bayai, Christina Bonaccorsi, David Campbell, Dan-Victor Giurgiutiu, Deepak Gulati, Christine Hawkes, Lisa Henry, Ashutosh Jadhav, Cynthia Kenmuir, Bradley Klein, Dustin Kliner, Kaustubh Limaye, Sunanda Nanduri, Forozan Navid, Pratit Patel, Srikant Rangaraju, Marcelo Rocha, John Schindler, Hazem Shoirah, Christopher Streib, Prasanna Tadi, Danoushka Tememe, Ruta Totoraitis, Greg Walker, Habibullah Ziayee, Lori Caufield, Carol Yeager, Jennifer Forbes, Karl Q. Schwart, Peter Knight, Frederick Ling, Curtis Benesch, Sahin Bogachan, George Hicks, Adam Kelly, Craig Narins, Thomas Stuver, Kathy Adams, Lynn Blair-Anton, Mary Lou Haynes, Carol Watts, Michael Baker, Lisa Mendes, Stephen Ball, Kashish Goel, Clayton Kaiser, Mark Robbins, David Zhao, Rashid Ahmad, Marshall Crenshaw, Joseph Fredi, Lisa Hermann, Steven Hoff, Howard Kirshner, Melissa Levack, Shilpi Mittal, Anne O'Duffy, Michael Petracek, Judy Baer, Grace Liang, Son Nguyen, Paul Heidenreich, Patricia Nguyen, Thomas Burdon, John Giacomini, Celina Yong, Maurice Buchbinder, James Fann, Shannon Kilgore, R. Scott Mitchell, Sharon McDaniel, Angelina Pack, Wendi White, Travis Young, Pam Burgess, Min Pu, Bharathi Upadhya, Robert Applegate, Neal Kon, Martinson Arnan, Sanam Baghshomali, Laura Bishop, Edward Bradbury, Sanjay Gandhi, Edward Kincaid, David Lefkowitz, Benjamin Lisle, Melissa Batteria, Elizabeth Rerisi, Kimberly Stepinowski, Tanya Senicola, John Goncalves, Scott Schubach, Richard Schwartz, Karin Antaky, Colleen Christiansen, Kevin Marzo, Kathleen Michel, Ajay Misra, Princy Varghese, Elizieta Wirkowski, Linda Levesque, Lissa Sugeng, Michael Cleman, John K. Forrest, Sabet Hashim, Abeel Mangi, Hardick Amin, Umer Darr, Michael Dewar, Osman Faheem, Arnar Geirsson, David M. Greer, Abdel Kaleel, Ryan Kaple, Alexandra Lansky, Brian MacGrory, Steven Pfau, Joseph Schindler, Craig Thompson, Teddy Youn, David Yuh, James Yun
Journal: JAMA Cardiology (2022)

In patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited.To report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial.SURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August and October 2021.Patients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis.The prespecified secondary end points of death or disabling stroke and other adverse events and hemodynamic findings at 5 years. An independent clinical event committee adjudicated all serious adverse events and an independent echocardiographic core laboratory evaluated all echocardiograms at 5 years.A total of 1660 individuals underwent an attempted TAVR (n = 864) or surgical (n = 796) procedure. The mean (SD) age was 79.8 (6.2) years, 724 (43.6%) were female, and the mean (SD) Society of Thoracic Surgery Predicted Risk of Mortality score was 4.5% (1.6%). At 5 years, the rates of death or disabling stroke were similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI, 0.85-1.22]; P = .85). Transprosthetic gradients remained lower (mean [SD], 8.6 [5.5] mm Hg vs 11.2 [6.0] mm Hg; P < .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm2 vs 1.8 [0.6] cm2; P < .001) with TAVR vs surgery. More patients had moderate/severe paravalvular leak with TAVR than surgery (11 [3.0%] vs 2 [0.7%]; risk difference, 2.37% [95% CI, 0.17%- 4.85%]; P = .05). New pacemaker implantation rates were higher for TAVR than surgery at 5 years (289 [39.1%] vs 94 [15.1%]; hazard ratio, 3.30 [95% CI, 2.61-4.17]; log-rank P < .001), as were valve reintervention rates (27 [3.5%] vs 11 [1.9%]; hazard ratio, 2.21 [95% CI, 1.10-4.45]; log-rank P = .02), although between 2 and 5 years only 6 patients who underwent TAVR and 7 who underwent surgery required a reintervention.Among intermediate-risk patients with symptomatic severe aortic stenosis, major clinical outcomes at 5 years were similar for TAVR and surgery. TAVR was associated with superior hemodynamic valve performance but also with more paravalvular leak and valve reinterventions.